BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING

    MDR report key: 1100504 · Received August 5, 2008

    Report

    Report Number
    6000002-2008-08337
    Event Type
    Death
    Date Received
    August 5, 2008
    Date of Event
    November 14, 2007
    Report Date
    January 24, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K926138
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPIRED IN 2007, POST OPERATIVELY DUE TO HEART FAILURE. REPORTEDLY THIS PT UNDERWENT SURGERY TO REPAIR THE MITRAL AND TRICUSPID VALVES AND ABLATION. PLEASE REFERENCE MFR. REPORT# 6000002-2008-08336.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4450M32 R-07J1827

    Patients

    Seq Age Sex Outcome Treatment
    1 Death